| Summary: | HIV is a chronic condition that can be managed through treatment with antiretroviral therapy (ART). The current goals of treatment are to suppress viral replication to prevent disease progression, HIV-related morbidity, and mortality; to restore or preserve immunologic function; and to prevent onward transmission of the virus. Early ART regimens were associated with high pill burdens and/or complex administration protocols. In addition, aging of the population of patients with HIV means increased pill burden for the treatment of comorbid conditions that become more common with age. Since ART is not curative and must be taken indefinitely to maintain virologic suppression, adherence to ART is important. High pill burdens and complex administration regimens have been linked to lower adherence. Therefore, any strategies that simplify administration and/or minimize pill burden, such as single-tablet regimens (STRs) containing fixed-dose combinations (FDCs), may lead to better adherence to ART in people living with HIV infection. A Notice of Compliance for darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF), as a complete regimen for the treatment of HIV type 1 (HIV-1) infection in adults and adolescents with no known mutations associated with resistance to the individual components of D/C/F/TAF, was granted by Health Canada on March 8, 2018. The recommended dosage of D/C/F/TAF FDC is one tablet taken orally once daily with food. The objective of this review is to conduct an appraisal of the clinical evidence and pharmacoeconomic evaluation submitted by the manufacturer
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